Oral Insulin – The Insulin Holy Grail!

inhaled insulin Oral Insulin, sometimes called inhaled insulin, has been the holy grail of diabetes management since insulin was first developed for human use in the 1920’s. While much pursued, it has been difficult, if not impossible to capture. However, this may have changed.

But first, let’s take a look at why scientists are working so hard to create the product, how inhaled insulin works, why it has been so hard to develop a workable solution.

Why an Oral Solution? What is it?

Most diabetics taking insulin injections would rather not. Clearly, this is not a hard conclusion to make! Often, this reluctance can lead to skipped injections and poorer blood glucose management.

Most people would rather take an insulin pill. However, an insulin pill is not a workable option because the digestive tract breaks down insulin before it can be absorbed into the blood stream and used effectively to process blood glucose.

So, oral insulin is being pursued to make it easier for diabetics to take insulin. What is meant by oral depends. Some companies have pursued inhaled insulin, meaning the drug is actually inhaled into the lungs. As discussed below, this method has met with some, but ultimately limited success.

Comparatively, insulin that is absorbed in the oral (mouth) cavity has achieved far greater success.

The Market

Obviously, all type 1 patients need insulin and many type 2 patients need it as well. Additionally, some postulate that the type 2 market for an oral solution could be even higher, since many type 2 diabetics on the fringe of needing insulin are less likely to take insulin injections, but may be far more open to taking an oral solution.

The World Health Organization estimates that as of 2000, there were 171 million diabetics in the world and they expect this number to grow to 366 million by 2030. The American Diabetes Association estimates that over 23 million Americans currently have diabetes and this number could rise to over 44 million by 2034.

Either way you look at it, the market demand for insulin is going higher, particularly if you can make it easier to take than an injection.

Notable Failures

As of May 2010, when this article was written, there were many failures in the inhaled insulin market and few successes. Before we get to the success portion, let’s take a look at how we got here.

Exubera. This oral insulin was developed by Nektar Therapeutics with the help of Pfizer. While showing great early promise, the product was abruptly dropped by Pfizer in 2007. Incredibly, Pfizer dropped the product without even telling Nektar before issuing its press release. The criticisms of the product were that the device used to inhale the insulin into the lungs, was almost “bong like”. Not a great marketing tool. Shortly after the product was discontinued, allegations of increased lung cancer risk were levied against the product.

Aerx iDMS. This inhaled insulin was a joint venture between Aradigm Corporation and Novo Nordisk. This was a fast acting insulin product. Again, the company abruptly discontinued this option to focus on developing a long lasting insulin inhalation product.

Alveair. Cormed was in the process of developing a promising oral insulin when it appears it abruptly suspended the program. The website does not appear to have been updated since 2005. There is unconfirmed speculation that the company may be testing the product oversees, but these rumors are just that, rumors.

There were numerous other products, and failures besides the above. However, you probably get the picture that it has been a difficult medication to create.

The First Oral Insulin Product?

Now let’s turn the focus to what is more current. The most promising oral insulin product is being developed by Generex Biotechnology. The product is called Ora-Lyn. It is inhaled into and absorbed within the oral cavity. The delivery device looks similar to an asthma inhaler called the RapidMist. It is fast acting insulin.

There are two current trials for the product in the United States. The first is a Phase III trial for Type 1 Diabetics. The expected completion of the trial is by the end of 2010. The identification number is NCT00668850.

The second trial is for patients with type 1 and type 2 diabetes. This is also a phase III trial, but no completion date was provided by the FDA. The trial number for this study is NTC00948493.

Updates can be found here.

Ora-Lyn is also under trial in at least 6 other countries and already being sold to patients in Ecuador. It is also approved for sale in India. The search for a long lasting oral insulin continues. Nonetheless, the ability to use an inhaler for short term needs around meals is a huge breakthrough in insulin technology and we look forward to further good news, hopefully later this year.

By Erich Schultz – Last Reviewed April 2012.